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Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies

Recruiting
- 50 years of age
Both
Phase N/A

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Overview

This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.

Description

Based on diagnosis and clinical history, a determination of the most appropriate regimen will be made based on the following prep plans:

Arm A: Fully Myeloablative Preparative Regimen, Arm B: Reduced Toxicity Ablative Preparative Regimen, Arm C: Reduced Intensity Conditioning, Arm D: No Preparative Regimen

Eligibility

Inclusion Criteria:

  • Diagnosis of immunodeficiency or histiocytic disorder including the following:
    • Severe combined immunodeficiency (SCID - all variants)
    • Second bone marrow transplant (BMT) for SCID (after graft rejection)
    • Omenn's Syndrome
    • Reticular dysgenesis
    • Wiskott-Aldrich syndrome
    • Major histocompatibility complex (MHC) Class II deficiency (bare lymphocyte syndrome)
    • Hyper IgM Syndrome (CD40 Ligand Deficiency)
    • Common variable immunodeficiency (CVID) with severe phenotype
    • Chronic Granulomatous Disease (CGD)
    • Other severe Combined Immune Deficiencies (CID)
    • Hemophagocytic Lymphohistiocytosis (HLH)
    • X-linked Lymphoproliferative Disease (XLP)
    • Chediak-Higashi Syndrome (CHS)
    • Griscelli Syndrome
    • Langerhans Cell Histiocytosis (LCH)
  • Acceptable stem cell sources include:
    • HLA identical or 1 antigen matched sibling donor eligible to donate bone marrow
    • HLA identical or up to a 1 antigen mismatched unrelated BM donor
    • Sibling donor cord blood with acceptable HLA match and cell dose as per current institutional standards
    • Single unrelated umbilical cord blood unit with 0-2 antigen mismatch and minimum cell dose of >5 x 10^7 nucleated cells/kg as per current institutional guidelines
    • Double unrelated umbilical cord blood units that are:
      • up to 2 antigen mismatched to the patient
      • up to 2 antigen mismatched to each other
      • minimum cell dose of at least one single unit must be ≥ 3.5 x 10^7 nucleated cells/kg
      • combined dose of both units must provide a total cell dose of ≥ 5 x 10^7 nucleated cells/kg
  • Age: 0 to 50 years
  • Adequate organ function and performance status.

Exclusion Criteria

  • pregnant or breastfeeding
  • active, uncontrolled infection and/or HIV positive
  • acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy

Study details

SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome, Bare Lymphocyte Syndrome

NCT01652092

Masonic Cancer Center, University of Minnesota

29 January 2024

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